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  • Location

    Leiden

  • Job title:

    Scientist (Medical Writer)

  • Sector:

  • Job ref:

    46928

  • Start Date:

    2021-10-26

The Company 
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.

Role Description 
As a Medical Writer Scientist you'll be supporting the transition from the development phase to a commercial product. You'll be mainly involved in authoring documents, data analysis and process validation. 

Responsibilities 
- Authoring and/or reviewing technical transfer reports
- Authoring and/or reviewing validation reports
- Assist on authoring BLA filing documentation and drafting answers for questions from health authorities, support during Pre-Approval inspection (PAI)
- Supports RSV-F process lead in her activities and back-up in her absence


Requirements 
Good technical writing skills and command of MS Word and MS Excel. Fully trained for TruVault
- Understanding of GMP documentation
- Able to retrieve and assess data from production systems (MBR, PI, DeltaV, eLIMS, etc…); perform gap assessments and communicate to SME’s
- Auditing/Inspections experience is a plus 


Other Information 
This positions is likely to be 80% remote // min. 1-2 days per week onsite. 
For more information please contact Ece Karakurt at e.karakurt@sire-search.com or +31 (0) 20 658 98 01